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The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014.

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Presentation on theme: "The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014."— Presentation transcript:

1 The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014

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4 IMP/IP IMP (Investigational Medicinal Product) / IP (Investigational Product) 1. Sourcing and Receipt 2. Storage 3. Dispensing/Blinding 4. Randomisation 5. Disposal/Destruction UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

5 IMP/IP IMP (Investigational Medicinal Product) / IP (Investigational Product) 1. Sourcing and Receipt 2. Storage 3. Dispensing/Blinding 4. Randomisation 5. Disposal/Destruction UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

6 Sourcing and Receipt Sponsor-driven Phase I: New IMP & Formulation Sponsor arranges manufacture Importing Dummy Dispensing Investigator-led Phase III: Typically Locally-Marketed Product Pharmacist sources IMP Dummy Dispensing Source of Accountability: Delivery waybills, Prescriptions, Invoices, Receipt Accountability UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

7 Sourcing and Receipt Sponsor-driven Phase I: New IMP & Formulation Sponsor arranges manufacture Importing Dummy Dispensing Investigator-led Phase III: Typically Locally-Marketed Product Pharmacist sources IMP Dummy Dispensing Source of Accountability: Delivery waybills, Prescriptions, Invoices, Receipt Accountability Receipt Accountability

8 IMP/IP IMP (Investigational Medicinal Product) / IP (Investigational Product) 1. Sourcing and Receipt 2. Storage 3. Dispensing/Blinding 4. Randomisation 5. Disposal/Destruction UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

9 Storage Certificate of Analysis (COA)  light, temperature, humidity Rigorous Control  E.g. fridges, air-con, probes, light protection Unique Storage Space Back-Up Plan Sources of Accountability: Temperature Logs, Calibration Certificates, SOPs, COAs UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

10 IMP/IP IMP (Investigational Medicinal Product) / IP (Investigational Product) 1. Sourcing and Receipt 2. Storage 3. Dispensing/Blinding 4. Randomisation 5. Disposal/Destruction UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

11 Dispensing Dispensing Licence Expiry Dates IP prep (e.g. reconstitution, infusion) Labelling requirements  e.g. Participant ID, Study/Protocol/Investigator ID, Quantity Dispensed, Mode of Delivery, Storage Condition, Exp./Lot/Batch #’s Blinding – implication for dispensing directly to patient Unblinding procedure Source of accountability: MCC documentation, Pharmacy Manual (accountability, labels, patient dispensing logs) UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

12 Sourcing and Receipt Sponsor-driven Phase I: New IMP & Formulation Sponsor arranges manufacture Importing Dummy Dispensing Investigator-led Phase III: Typically Locally-Marketed Product Pharmacist sources IMP Dummy Dispensing Source of Accountability: Delivery waybills, Prescriptions, Invoices, Receipt Accountability Store Accountability

13 IMP/IP IMP (Investigational Medicinal Product) / IP (Investigational Product) 1. Sourcing and Receipt 2. Storage 3. Dispensing/Blinding 4. Randomisation 5. Disposal/Destruction UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

14 Randomisation Treatment Allocation/Dispensing Generated by statistician/pharmacist (sponsor or site produced), stored in secure location e.g. pharmacy file  Randomisation schedule or Automated system e.g. IVRS Randomisation log Source of accountability: Randomisation schedule and Randomisation logs UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

15 Sourcing and Receipt Sponsor-driven Phase I: New IMP & Formulation Sponsor arranges manufacture Importing Dummy Dispensing Investigator-led Phase III: Typically Locally-Marketed Product Pharmacist sources IMP Dummy Dispensing Source of Accountability: Delivery waybills, Prescriptions, Invoices, Receipt Accountability Randomisation Schedule Accountability

16 Sourcing and Receipt Sponsor-driven Phase I: New IMP & Formulation Sponsor arranges manufacture Importing Dummy Dispensing Investigator-led Phase III: Typically Locally-Marketed Product Pharmacist sources IMP Dummy Dispensing Source of Accountability: Delivery waybills, Prescriptions, Invoices, Receipt Accountability Randomisation Log Accountability Randomization Log for: ACTIVE IMP Randomization Log for: PLACEBO FOR IMP

17 IMP/IP IMP (Investigational Medicinal Product) / IP (Investigational Product) 1. Sourcing and Receipt 2. Storage 3. Dispensing/Blinding 4. Randomisation 5. Disposal/Destruction UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

18 Return/disposal At conclusion of study, final inventory and reconciliation Sponsor-driven: return to sponsor for disposal or site arranges disposal Arrange with waste disposal company Source of accountability: Disposal/Destruction Log UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

19 Sourcing and Receipt Sponsor-driven Phase I: New IMP & Formulation Sponsor arranges manufacture Importing Dummy Dispensing Investigator-led Phase III: Typically Locally-Marketed Product Pharmacist sources IMP Dummy Dispensing Source of Accountability: Delivery waybills, Prescriptions, Invoices, Receipt Accountability Destruction Log Accountability

20 SUMMARY Importance of pharmacy role: maintains accountability of IMP from start to finish, ensuring right dose given to right patient at the right time Accountability is a continuous process from start of study until closure Inform/involve pharmacy at the outset Resources available on CRC website - http://www.crc.uct.ac.za/ http://www.crc.uct.ac.za/ UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

21 SUMMARY Importance of pharmacy role: maintains accountability of IMP from start to finish, ensuring right dose given to right patient at the right time Accountability is a continuous process from start of study until closure Inform/involve pharmacy at the outset Resources available on CRC website - http://www.crc.uct.ac.za/ http://www.crc.uct.ac.za/

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23 | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014 Questions?


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